Statement of CSPI President Dr. Peter Lurie

The Food and Drug Administration’s internal report offers a comprehensive look at just how much work the FDA and Congress have before them in order to steer the agency’s troubled food program back on course. The report focuses on the crisis that left parents scouring supermarket shelves for infant and specialty formulas for much of the spring and summer, but cuts much deeper, shining a self-critical spotlight on the many issues that have plagued the agency, from updating outdated technology to recruiting and training qualified staff. The report contains 15 wide-ranging recommendations to improve the work of the agency, and touches on existing authorities and resources FDA will need from Congress to make true reform possible.

The report’s fundamental conclusion is that “[t]here is no single action to explain the events that occurred, rather the report identifies a confluence of systemic vulnerabilities.” While this conclusion is undoubtedly true, the report is so thin on details that it’s hard to make sense of what actually transpired. For example, the report concludes that “[c]onditions observed at the Abbott Nutrition facility were not consistent with a strong food safety culture,” but provides no specifics, even though some descriptions of the conditions at the plant have already appeared in press coverage. Similarly, the report mentions that “[a] complaint sent via mail and other delivery systems by a confidential informant to agency leaders at FDA’s White Oak campus was not delivered to the addressees,” but does not make clear what the basis for the complaint was, to whom the communication was addressed, why the communication was not passed on, or whether any remedial action has been taken.

Still, even without a clear recitation of the factual underpinnings of the shortage, the report suggests that FDA has sincerely sought to learn from these events and identifies a series of practical remedies to avert a recurrence. Many of these recommendations will take years to implement, but this is a solid start. Primary among these are resources for a dedicated staff at the food agency to monitor the supply chain of infant and specialty formulas, and — although the report treads lightly here — the authority to require manufacturers to notify FDA of circumstances that could lead to a shortage. Congress should take these requests seriously, including by passing a pending bill re-authorizing user fees to the agency, which could provide FDA with additional tools to identify and address potential formula shortages.

Peter G. Lurie, MD, MPH served as FDA Associate Commissioner for Public Health Strategy and Analysis from 2014-2017, where his duties included the agency's response to drug shortages.

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